Tens of millions of people in the United States struggle with obstructive sleep apnea, a condition that occurs when the throat muscles narrow during sleep, leading to temporary pauses in breathing that can cause people to snore and jolt awake, gasping for air.
Poor sleep can leave people feeling exhausted, irritable and unfocused during the day. And if left untreated, sleep apnea can increase the risk for serious conditions like high blood pressure, Type 2 diabetes, heart attack and stroke.
For decades, the primary treatment for sleep apnea has been continuous positive airway pressure (or CPAP). Before bed, those with the condition put on a face mask that is connected to a CPAP machine, which keeps the airway open by forcing air into it. The machines are effective, but many find them so noisy, cumbersome or uncomfortable that they end up abandoning them.
Now, a more appealing option may be on the way, according to a news release from Apnimed, a pharmaceutical company focused on treating sleep apnea. On Wednesday, the company announced a second round of positive Phase 3 clinical trial results for a first-of-its-kind oral pill that can be taken just before bedtime to help keep a person’s airway open.
The full results have not yet been released, or published in a peer-reviewed journal. But the findings build on past, similarly positive conclusions from trials and studies. Sleep experts say that what they’re seeing in reports so far makes them think the pill could be a game changer.
Dr. Phyllis Zee, a sleep doctor and researcher at Northwestern Medicine who was not involved with the trial, said that if approved, the drug could transform the lives of many. That includes not only those who can’t tolerate CPAP machines, but also those who can’t — or prefer not to — use other interventions, such as other types of oral devices or weight loss medications. (Excess weight is a risk factor for sleep apnea.)
How does the new drug work?
Dr. Sanjay R. Patel, a sleep researcher at the University of Pittsburgh who led the new trial, described trying to breathe through a constricted airway like slurping soda through a soggy paper straw.
“If that straw is really floppy, then when you suck, you suck the walls shut and you cant get any of the soda,” he said.
The new pill, called AD109, is a combination of atomoxetine and aroxybutynin, two drugs that tell your brain to keep the airway muscles activated throughout the night, leaving the breathing path clear.
The drugs “essentially trick those muscles into thinking they’re awake,” said Dr. Daniel Combs, an associate professor of pediatrics and medicine at the University of Arizona, who was not involved with the trial but is studying a drug similar to AD109.
The new trial included 660 adults with sleep apnea who either couldn’t tolerate CPAP machines or refused to use them. According to Apnimed’s news release, AD109 significantly reduced the average number of hourly breathing interruptions in participants who took the pill, compared with those given a placebo.
Some participants who took the pill did report side effects, including dry mouth and insomnia, said Dr. Larry Miller, the chief executive of Apnimed. But the company has not published detailed data about those side effects. According to Dr. Miller, who has a medical degree, just 3 percent of the patients who took AD109 found the insomnia significant enough to stop taking the drug.
Dr. Sairam Parthasarathy, a sleep researcher at the University of Arizona who was not involved with the trial, said it would be helpful to review the full data on the side effects, as well as other evidence on how well the drug works in people with chronic conditions like heart disease or severe obesity. (People with sleep apnea often have these conditions at the same time.)
It’s unclear how much the drug will cost, and whether insurers will cover it. Some researchers also wondered whether the drug would improve daytime fatigue and mood.
Even so, it could be “a big deal for patients,” Dr. Parthasarathy said. Many people with sleep apnea are so averse to using CPAP machines that they don’t seek treatment. He said he would prescribe the drug based on the results of this trial and others.
Apnimed plans to share the complete data, including how well the pill reduced snoring, in October, Dr. Miller said. He added that the company intended to seek approval from the Food and Drug Administration in early 2026.
Dr. Miller said he was optimistic that the clinical trial results would support an F.D.A. approval, but if or when that might happen is unclear, especially given recent changes at the agency.
Could the pill replace other sleep apnea treatments?
When used properly, CPAP machines are currently the most effective option for treating sleep apnea. And many people become acclimated to them, especially after the devices start improving their sleep quality. But for those resistant to using the devices, the pill could be an effective alternative.
Ultimately, the more treatment options, the better, said Dr. Zee. Whether you use a CPAP machine, a pill or something else, treating sleep apnea can improve “just about everything,” Dr. Combs said.
One of his favorite studies, he said, was a small one from 2013 that found that golfers who treated their sleep apnea with a CPAP machine tended to perform better at the game — the implication being that they were more rested.
“It makes a huge difference,” Dr. Combs said.
Caroline Hopkins Legaspi is a Times reporter focusing on nutrition and sleep.
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